The Indonesia vaccine stand-off

The stand-off between Indonesia and the rest of the world over sharing of viral isolates obtained within its borders continues. Indonesia has identified a problem, but in our opinion, has no standing to impose its proffered unworkable solution. Everyone tends to see this from their own particular perspective, so we'll give you ours. We aren't WHO (and have had no contact with them on this matter) and we aren't citizens of Indonesia or any other developing country. We are citizens of a rich, developed country. But we are also long time, committed public health professionals. I think we have said enough here to establish we don't take the position that once we get ours, the rest of the world can do what it wants. We are all in this together. But you'll have to decide for yourself, after hearing us out, if we make sense. We don't think Indonesia does.

Influenza virus changes its immunological characteristics continually, so the only way to make an effective vaccine is to monitor it continually, hoping that we can predict what it will look like in the coming flu season so we can make an effective vaccine against it in time. There are two parts to this. The first is a timely surveillance system that can identify the likely circulating strain in the next flu season. When that decision is made, the appropriate viral seed is made freely available so that any production facility capable of making vaccine can do so. The production from the identified likely strain for the next season is the other part. For many decades member states have made available to WHO isolates of influenza viruses taken from within their borders. Analyzing and compiling this information is the core of the surveillance part of the system. It has worked well, until now. But Indonesia doesn't like what happens next, so it is throwing a monkey wrench into the surveillance system and in doing so affecting every other nation.

The system may be broken, but it is part 2 that's at fault, not the front-end surveillance system Indonesia is threatening to wreck. Indonesia and other developing countries are rightly concerned about whether they will be able to afford any vaccine made by pharmaceutical companies based in the developed world or China. It's a legitimate concern. However their proposed solution -- to require permission from any production facility that wants to use isolates from Indonesia -- is not only unworkable but will do real damage to the current system of influenza surveillance and vaccine production by replacing it with something far worse. In essence it will create chaos as each country picks and chooses which companies or countries (if there is a national vaccine institute) will have the "right" to make a vaccine from virus isolated from within the originating country's borders. The idea that a country "owns the rights" to a virus is nonsensical on its face, although it is the foreseeable and regrettable consequence of the rapacious system of intellectual property fashioned by Big Pharma and other powerful interests. You should not be able to patent a virus or a life form. Period.

There is no easy solution to this problem because the world's productive capacity for influenza vaccine is currently only about 350.000,000 doses a year, although it might be pushed to 500,000,000. Thus the global output in the best of circumstances is only about twice the population of Indonesia. Even if every vaccine facility agreed to put 10% of its output in a stockpile for the developing world, that would only be 50,000,000 doses. Remember, that's yearly output. The scale of a pandemic is on the order of months.

Thus there are two major problems to be solved. One is the grossly insufficient global productive capacity for influenza vaccine. The other is that the "market" doesn't work for influenza vaccines. Commercial enterprises cannot and will not ramp up production without some confidence the product can be sold for a profit, a profit that must exceed what can be obtained by investing the money in some alternative product, like an anti-impotence drug or a variant antibiotic. Investing in facilities that might regularly be underutilized or with redundant capacity doesn't make sense for them, although that is just what is needed for the spiky and irregular influenza setting. The restrictive and unfair intellectual property laws compound the problem.

If you aren't going to use the market, what then? Our preferred solution -- although we are open to others that can solve the twin problems of insufficient capacity and poor response to need rather than market demand -- would be internationally supported regional vaccine institutes making vaccine at cost for their region. They could be modular or multifacility, but would overproduce vaccine so as to have both an inventory and a productive capacity that exceeds, perhaps by a wide margin, the yearly demand. It's inefficient and expensive to do this. But not as inefficient and expensive as the costs of an outbreak, epidemic or pandemic. An insurance policy you don't cash in is always inefficient and expensive. You still buy insurance.

Meanwhile, Indonesia holds the influenza surveillance system ransom -- for what? They will get nothing out of their solution. They might not even have any company willing to use their isolates, so there would be no one to grant permission to. If Indonesia, possessed of weak and highly decentralized government would get 5,000,000 doses of vaccine for its 250,000,000 people, I think we can guess how it would be distributed and to whom.

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Uh...Amen.

By M. Randolph Kruger (not verified) on 10 May 2007 #permalink

I see your point. But what other card does Indonesia or any other non-developed country have to play? What are they to do, wait until the Pharmaceutical companies donate a 'regional vaccine center' to compete with them? Or maybe the US government will give a couple of hours of Iraq expenses. I don't see what other choice they have. Cooperating has gotten them nowhere.

Ron: Cooperating has gotten them the same place as most others, including you and me (do you really think we will be first in line for vaccines?). They are part of an international system that produces seasonal flu vaccine and has done so for decades. To the extent they used any of those vaccines for their citizens they benefitted and to the extent that protection elsewher also protected them, they benefitted. If the pandemic strain is isolated elsewhere does this mean they should not get vaccine?

What else are they to do? Push for a regional system (they haven't). And not do what they are doing. It's not like wrecking the current system is forced on them. They have identified the problem, which has been evident for a long time. Their "solution", to make a virus property and use it to bargain with, is a recipe for disaster and everyone knows it. They are doing it because they can.

I totally agree, but here's my question. What have they got to lose?

It's like the kid who gets told he can't build the sandcastle with everyone else, so he comes by and kicks the whole thing over.

And there is another problem. With your perception, revere, if you don't mind me shooting straight.

You have to distinguish between Indonesia as a country and individual Indonesian officials as, well, individuals.

As the former, there are niceties called the international system to worry about. As the latter, well, right now they are the hottest show in town. You want to bet how many different entities are fighting to line these guys pockets till they say yes? To something, to whatever.

That 'yes' has a price. Which hasn't been reached yet.

I think there is a part of the issue that is missing here. Indonesia is not only withholding the samples of your run-of-the-mill flu surveillance to predict a better yearly flu vaccine--which mostly ends up in the arms of the developed countries.

It is preventing sharing of H5N1 bird-flu samples.

These are the H5N1 viruses that may cause a massive pandemic the scope of which the world has never seen, or they may only cause single zoonotic infections caused by direct bird-to-human contact. You'd think that Indonesia would want to know which one of those possibilities is more likely, but in order to do that, they need to send samples so that places like the CDC can investigate them.

In addition, if a strain of H5N1 does evolve in Indonesia which is able to easily transmit from person-to-person, and we are able to make a timely and effective vaccine, I would be willing to bet we would have nearly every available dose of the vaccine on military transport to the outbreak region to try to stop transmissible bird-flu before it spreads. We can talk about the ethics behind forced vaccination of a country with an experimental vaccine, but I doubt they would be unable to get the vaccine. That is, as long as it was made quickly and was available before the transmissible bird-flu could spread across the world. This means that the thing with the greatest potential to devastate Indonesia in the case of a transmissible bird-flu would be if they haven't been sending samples to the WHO and CDC for research.

I can see that they want to get more money out of the pharmaceutical companies making money of the yearly flu shots here, but I'm not sure if they realize what they are risking.

metzgerm: No, I hope that's not missing. We have covered this issue extensively (see other links in the post). H5N1 is a special case and is what the Indon strategy is all about. But it is part of the sureillance system in general.

revere: True, I had landed on this post directly and had not yet read your previous posts that do talk specifically about bird-flu/H5N1/pandemic influenza.

I was trying to make the point that I can understand that Indonesia is getting the short end of the stick regarding surveillance of non-H5N1 flu--they give the samples, but the normal yearly flu vaccine will not likely provide any benefit for people of that country. For H5N1, however, the generation of a vaccine has a direct and real benefit for Indonesians. If we just tell Indonesia that all surveillance helps them, they should be rightly skeptical, but if they understand the potential benefit to them from research on H5N1 they would realize how foolish the block on sending samples really is.

So I'm not exactly disagreeing with you, but I think this dichotomy is a key part of the discussion that is easily overlooked, and arguments can become disconnected when the parties arguing are each thinking about opposite sides of the issue. H5N1 is a special case, in more ways than one.

If the Indonesian government want to make any bird-flu/H5N1/pandemic virus their property, I want them to compensate me and my country for any harm their 'property' does to me and my country. If they breed a pandemic by bad public health management, then they are morally liable for the harm it causes. If they then claim property rights over the resultant virus and disrupt efforts to minimise its harm, then they are responsible for the harm.

Davidp-It is, and could be largely considered to be a national security issue for the UN. This is one of those ambiguously worded things in the charter. E.g. an invasion, attack, or WMD could logically but morally questionable be used on the Indonesians if they dont pony up the samples and sequences, or if they hold a national against that governments will.

China has a load of workers in that country right now. You can assume that many of them are spies and they are sending info out to Beijing. There were several nuke tipped cruisers in the S. China Sea and off Java in the last few months although a few of my sources havent had tabs on them.

Paint a picture.... The Chinese have workers there to get sick and only sick. If they work in the meantime thats cool too. They become ill and they are hospitalized but as Chinese nationals they are the property of their nation. They have every right to remove them with the Indonesian intellectual property in their body. So do the Indons resist and get their asses swacked? Court of public opinion would be totally against the Indons and its pretty much that way now.

Desparate people do desparate things. If there is a massive bloom in Indon of BF what would the governments of the world do? Chem weapons? Nukes? I dont know. Chem weapons that would kill every air breather is one option if it goes to the military. Revere would want a medical response that wouldnt contain it. The military one would for sure slow it down but not stop it as it only takes one bird to kill the planet.

One thing is sure the willingness to commit to an action would be in reaction to what the Indons are doing now. It isnt much, they are stealing the money sent in there as fast as it hits the bank accounts and BF continues to spread.

By M. Randolph Kruger (not verified) on 13 May 2007 #permalink